Finland actively contributed to the European medicines regulatory network in 2021
The European Medicines Agency (EMA) has published its annual report for 2021. The report details the joint activities and processes of the European medicines regulatory network as well as the resources used. Fimea is the competent national authority that participates in the network on behalf of Finland, and the key figures for the network’s activities reveal Finland's expert contribution in joint EU processes.
Accelerated procedures for COVID-19 vaccines and medical treatment
The pandemic caused by coronavirus brought plenty of extra work for the European medicines regulatory network. Coronavirus vaccines were assessed, just as other biological medicines are, through a centralised procedure coordinated by the European Medicines Agency, but in this case on a rolling basis and at an accelerated pace. Based on assessments and recommendations made by the Committee for Medicinal Products for Human Use (CHMP), the EU Commission granted marketing authorisations to four coronavirus vaccines and five medicines for the treatment of coronavirus. (EMA Annual Report 2021, p. 13). As the national vaccination campaigns progressed, the safety of coronavirus vaccines was monitored particularly closely – and based on a shorter monitoring cycle – through cooperation between the Pharmacovigilance Risk Assessment Committee (PRAC) and national medicines agencies.
Excelling as a provider of scientific advice and assessments
Fimea offers the expertise of its specialists for use in the joint processes for which EMA appoints specific teams. National agencies compete with one another for these assignments, as the agencies are paid for their contribution, and the work offers prime vantage points for the pharmaceutical development sector.
Fimea has actively invested in scientific advisory work. With a tally of 111 advisory assignments, Finland ranks sixth among the different national medicines agencies. Finland also actively participates in multinational advisory work (10 assignments). (EMA Annual Report 2021, p. 124).
Fimea’s experts have also been assigned rapporteur tasks (10), which are received from the Pharmacovigilance Risk Assessment Committee (PRAC). The countries that are equally active in rapporteur work included Austria, Denmark and Sweden, as well as the large agencies of Germany and the Netherlands. (EMA Annual Report 2021, p. 121).
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has assigned seven rapporteur or co-rapporteur tasks to Fimea’s experts, and Fimea has also been appointed to one of the parallel reporting tasks as part of a multinational assessment team. (EMA Annual Report 2021, p. 122). Fimea’s experts have also been assigned a co-rapporteur task for one new evaluation of a veterinary medicinal product (EMA Annual Report 2021, p. 123). In addition, Fimea's experts have also been actively involved in work to combat antimicrobial resistance in areas such as collecting sales and use data on veterinary antimicrobials and promoting responsible use of antimicrobials.
Assessment tasks for new medicinal products require special expertise
In addition to requiring regulatory competence, obtaining demanding and competitive evaluation tasks also calls for special expertise. Fimea has accumulated expertise in its selected strategic focus areas, such as biopharmaceuticals (including biosimilars and advanced therapy medicinal products, ATMP).
The medicinal treatments of the future will be more sophisticated and more personalised. Fimea has also already obtained the expertise needed for evaluating various cancer medicines and medicinal treatments for autoimmune diseases, and this too is reflected in the number of evaluation tasks received by Fimea experts.
EMA Annual Report 2021 (pdf)
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